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Cancer Chemotherapy and Pharmacology

, Volume 30, Supplement 1, pp S26–S30 | Cite as

A prospective randomized study of prophylaxis of tumor recurrence following transurethral resection of superficial bladder cancer-intravesical thio-TEPA versus oral UFT

  • Yoshihiko Hirao
  • Eigoro Okajima
  • Seiichiro Ozono
  • Shoji Samma
  • Kenji Sasaki
  • Tadashi Hiramatsu
  • Katsuhiro Babaya
  • Shuji Watanabe
  • Yoshio Maruyama
Intravesical Instillation I. Prophylactic Therapy Transurethral Resection, Superficial Bladder Cancer, Thio TEPA

Summary

The long-term prophylactic effect of chemotherapy following transurethral electroresection of bladder tumors (TUR-Bt) was investigated using three different modalities: no prophylactic treatment (group C); oral UFT given at 1296 mg/day for 2 years (group U); and intravesical thio-TEPA at 30 mg/30 ml physiological saline, instilled 32 times over 2 years (group T). Patients newly diagnosed as having superficial bladder cancer (stage, ≦pTlb; grade, ≦G2) who had undergone TUR-Bt at Nara Medical University and its affiliated hospitals between November 1986 and March 1990 were allocated to one of the three groups by the envelope method. The initial treatment was maintained until the third recurrence or disease progression, except for TUR-Bt which was performed at the time of recurrence. The registered cases included 51 patients in group C, 50 in group U, and 52 in group T, and the number of evaluable cases in each group were 48, 47, and 45, respectively. The non-recurrence rates at 3 years were 54% in group C, 67% in group U, and 85% in group T, and the difference between groups T and C was significant. In terms of the tumor grade and stage, No significant difference was observed among the groups in the category of G1 or Ta tumors, but the non-recurrence rates determined in group T for G2 or T1 tumors were significantly higher than those obtained in group C. Moreover, no significant difference was found among the groups in relation to solitary tumors, but the non-recurrence rate obtained in group T for multiple tumors was significantly higher than that determined in group C. The overall cumulative recurrence rate in each group was 3.07 in group C, 1.95 in group U, and 0.70 in group T, and that determined according to tumor grade, stage, and multiplicity was also highest in group C, followed by group U and group T. The main adverse effects encountered were upper gastrointestinal (GI) symptoms (8.5%) in group U and irritable bladder (11.1%) in group T. Intravesical instillation of thio-TEPA tended to produce greater preventive efficacy than did oral UFT during the early postoperative period, but the prophylactic efficacy of thio-TEPA and UFT should be elucidated over a longer observation period.

Keywords

Tumor Grade Bladder Tumor Transurethral Resection Superficial Bladder Cancer Intravesical Instillation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. 1.
    Akaza H, Isaka S, Koiso K, Kotake T, Machida T, Maru A, Matsumura Y, Niijima T, Obata K, Ohe H, Ohi Y, Shimazaki J, Tashiro K, Ueda T, Uyama T, the Japanese Urological Cancer Research Group for Adriamycin (1987) Comparative analysis of short-term and longterm prophylactic intravesical chemotherapy of superficial bladder cancer. Prospective, randomized, controlled studies of the Japanese Urological Cancer Research Group. Cancer Chemother Pharmacol 20[Suppl]:S91Google Scholar
  2. 2.
    Babaya K, Takahashi S, Momose H, Matsuki H, Sasaki K, Samma S, Ozono S, Hirao Y, Okajima E (1987) Effect of single chemotherapeutic agents on development of urinary bladder tumors induced byN-butyl-N-(4-hydroxybutyl)-nitrosamine (BBN) in rats. Urol Res 15:329Google Scholar
  3. 3.
    Hirao Y, Okajima E, Ohara S, Ozono S, Hiramatsu T, Yoshida K, Yamada K, Aoyama H, Hashimoto M, Watanabe S (1987) Prophylactic treatment for superficial bladder cancer following transurethral resection. Cancer Chemother Pharmacol 20 [Suppl]:S85Google Scholar
  4. 4.
    Ichikawa T, Japan Research Group of Bladder Carcinoma (1972) Clinical application of 2,5-di-O-acetyl-β-d-glucaro(1→4)-(6→3)-dilactone (SLA) to bladder tumors, with special reference to its effect on the frequency of tumor recurrence. J Urol 108:571Google Scholar
  5. 5.
    Jones HC, Swinney J (1961) Thio-TEPA in the treatment of tumors of the bladder. Lancet II:615Google Scholar
  6. 6.
    Koontz WW Jr, Prout GR Jr, Smith W, Frable WJ, Minniss JE (1981) The use of intravesical thio-tepa in the management of noninvasive carcinoma of the bladder. J Urol 125:307Google Scholar
  7. 7.
    Mishina T, Oda K, Murata E, Ohe H, Mori Y, Takahashi T (1975) Mitomycin C bladder instillation therapy for bladder tumors. J Urol 114:217Google Scholar
  8. 8.
    Rübben H, Hautmann R, Dahm HH (1983) Bladder tumor induction by cytotoxic agents-clinical experience and experimental data. World J Urol 1:94Google Scholar
  9. 9.
    Schulman CC, Denis LJ, Oosterlinck W, De Sy W, Chantrie M, Bouffioux C, Van Changh PJ, Van Erps P (1983) Early adjuvant Adriamycin in superficial bladder carcinoma. World J Urol 1:86Google Scholar
  10. 10.
    Soloway MS (1980) Rationale for intensive intravesical chemotherapy for superficial bladder cancer. J Urol 123:461Google Scholar
  11. 11.
    Soloway MS (1987) Evaluation and management of patients with superficial bladder cancer. Urol Clin North Am 14:771Google Scholar
  12. 12.
    Studer UE, Biedermann C, Chollet D, Karrer P, Kraft R, Toggenburg H, Vonbank F (1984) Prevention of recurrent superficial bladder tumors by oral etretinate: preliminary results of a randomized, double-blin multicenter trial in Switzerland. J Urol 131:47Google Scholar
  13. 13.
    Ueda T, Iguchi A, Sagiyama K, Osada Y, Ariyoshi A, Omoto T, Kumazawa J, the Kyushu University Urological Oncology Group (1987) Early intravesical instillation of Adriamycin with oral administration of 5-fluorouracil after transurethral resection for superficial bladder cancer: preliminary results. Cancer Chemother Pharmacol 20 [Suppl]:S81Google Scholar
  14. 14.
    Zinke H, Utz DC, Taylor WF, Myers RP, Leary FJ (1983) Influence of thiotepa and doxorubicin instillation at time of transurethral surgical treatment of bladder cancer on tumor recurrence: a prospective, randomized, double-blind, controlled trial. J Urol 129:505Google Scholar

Copyright information

© Springer-Verlag 1992

Authors and Affiliations

  • Yoshihiko Hirao
    • 2
  • Eigoro Okajima
    • 2
  • Seiichiro Ozono
    • 2
  • Shoji Samma
    • 2
  • Kenji Sasaki
    • 1
  • Tadashi Hiramatsu
    • 1
  • Katsuhiro Babaya
    • 1
  • Shuji Watanabe
    • 1
  • Yoshio Maruyama
    • 1
  1. 1.Nara Urologic Oncology Research GroupNaraJapan
  2. 2.Department of UrologyNara Medical UniversityKashihara, NaraJapan

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